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Biomarkers, Neurodevelopment and Preterm Infants

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02557191
Enrollment
4
Registered
2015-09-23
Start date
2015-04-30
Completion date
2018-12-31
Last updated
2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epigenetic Changes, Neurodevelopmental Disorder, Preterm

Brief summary

Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.

Interventions

OTHERObservational study

Sponsors

Albert Einstein College of Medicine
CollaboratorOTHER
Montefiore Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Days
Healthy volunteers
No

Inclusion criteria

* \<32 weeks gestation * Born at Weiler Division of Montefiore

Exclusion criteria

* Intraventricular hemorrhage * Chromosomal abnormalities * Congenital viral conditions

Design outcomes

Primary

MeasureTime frameDescription
Brain white matter development38-42 weeks adjusted ageBrain MRI

Secondary

MeasureTime frameDescription
Neurodevelopment38-42 weeks adjusted ageAdministration of NICU Neonatal Neurobehavioral Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026